Battle over phthalates heats up

Phthalate plasticizers are used to soften plastic products such as IV bags and toys.

September 28, 1999
Web posted at: 3:30 p.m. EDT (1930 GMT)

A critique was released last week disputing claims made by a group headed by former Surgeon General C. Everett Koop that phthalates - chemicals used to soften plastics in vinyl medical products and toys - are safe.

A doctor commissioned by Health Care Without Harm reviewed a report on the safety of phthalates released by a "blue ribbon" panel of specialists headed by Koop, and found it to have factual errors and omissions in data. Health Care Without Harm is a coalition of 180 organizations concerned with eliminating environmental pollution from health care.

Phthalate plasticizers are thought to leach out of the products made with them, and the question is whether these chemicals cause harm to people who have been exposed to them. The coalition is a proponent of using other non-vinyl materials that do not contain phthalates as an alternative to the vinyl products that do contain the chemicals.

Dr. Koop's gathering of medical and scientific experts convened in February to examine the issue of whether phthalates were harmful and released their results in June, saying that consumers did not need to worry about adverse effects.

The Koop report was released at the same time as another commissioned by Health Care Without Harm conducted the Lowell Center for Sustainable Production at the University of Massachusetts at Lowell. The HCWH report had very different results, finding that DEHP, a member of the phthalate family, has negative health effects on both humans and animals.

The HCWH report was based on the review of 100 studies on DEHP that concluded the substance could harm multiple organs and interfere with sperm production.

"I am deeply disappointed that a physician with Dr. Koop's reputation as
'America's family doctor' has produced a report based on an incomplete, deceptive and misleading analysis of the scientific literature," said Dr. Ted Schettler of the Science and Environmental Health Network. Schettler authored the recent critique of Dr. Koop's report.

Shortly after the analysis of their report was released, the ACSH released a statement refuting the criticisms made by Schettler and defending the methodology utilized by the blue ribbon panel.

"The American Council on Science and Health is disappointed, but not surprised, by activists continued attempts to discredit a panel of well-respected, nationally and internationally recognized scientific and medical professionals, headed by the former U.S. Surgeon General Dr. C. Everett Koop," the statement said. "Once again, there has been an attempt to shift attention from sound science to misrepresentations and half-truths."

The Koop/ACSH report was submitted to the National Toxicology Program of the National Institute of Environmental Health Sciences and to the Food and Drug Administration. Jack Moore, a toxicologist for the Center for Evaluating Risk to Human Reproduction, which is funded by the NTP, said that the NTP had no official comment yet on the ACSH study.

The NTP is holding a meeting in December to determine the toxicological effect that phthalates have on the reproductive and developmental processes in humans, and the ASCH study will be considered then.

The Koop report was also presented to the U.S. Food and Drug Administration for review. According to an FDA spokesperson, researchers at FDA are currently carrying out risk assessment studies of DEHP and are taking into account both the Health Care Without Harm and the ACSH/Koop reports during their procedures.